Senior Regulatory Affairs Associate
SRAA_4266894723
Posted: 15/07/2025
- Sydney, New South Wales, Australia (Hybrid)
- Permanent
Join a global medical device business in a senior regulatory role with genuine scope and influence. This organisation has built a strong and trusted presence across ANZ and continues to expand its footprint. Known for its collaborative culture and diverse product portfolio, the business is now looking for an experienced Senior Regulatory Affairs Associate to join its local RA team and take the lead on a variety of strategic, hands-on responsibilities.
This is an exciting opportunity for a senior RA professional who enjoys a mix of technical depth, cross-functional collaboration, and leadership. You’ll work closely with both local and global teams, support regulatory strategy and compliance, and provide day-to-day guidance to offshore colleagues.
Responsibilities:
- Reviewing and assessing technical documentation to ensure product compliance with regional regulatory standards and performance expectations.
- Managing and maintaining regulatory files to support ongoing product registrations and local conformity assessments.
- Staying across evolving global and local regulatory standards and applying relevant changes to product claims, technical documentation, and internal processes.
- Leading cross-functional regulatory projects tied to product changes, continuous improvement, and broader regulatory reform initiatives.
- Working closely with internal teams across quality, clinical, supply chain, and commercial to support timely market access and successful product launches.
- Supporting the development of team capability by sharing expertise and promoting best practice regulatory approaches across the group.
Skills:
- Proven experience working in regulatory affairs within the medical device sector, ideally with exposure to a broad product portfolio.
- Sound knowledge of local regulatory requirements, including TGA guidelines, Essential Principles, and UDI frameworks.
- A working understanding of international regulatory pathways and standards, such as EU MDR, FDA, or MDSAP.
- Experience preparing or reviewing technical documentation to support regulatory submissions and ongoing compliance.
- Strong communication and collaboration skills, with the ability to work effectively across local and global teams.
- Any prior experience guiding or mentoring others.
Apply directly now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (04) 21776703
Ben Byrne
Senior Recruitment Consultant
